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In 2007, the dollars spent on breast augmentation surgery in the United States was $1.5 billion. By 2012, the numbers are projected to top 2 billion per year. Statistics from The American Society of Plastic Surgeons show that breast augmentation headed the list of surgical procedures in 2008. For those women who have had mastectomies, implants will be presented as a standard part of the recovery process.
Carol Ciancutti-Leyva, director of the documentary “Absolutely Safe,” is the daughter of a cancer survivor. Her mother’s journey, from a double mastectomy to silicone implants in the early 70s – which resulted in chronic illness, formed the impetus for the film.
The documentary came out in 2007, after a ten-year struggle for funding. It is currently being booked for screenings on college campuses and is being used in classrooms devoted to women’s studies, bioethics, and public policy.
Currently, Ciancutti-Leyva is working to create strategic partnerships to mobilize an “Informed Consent” campaign about the use of breast implant devices. Her model for legislation is a New York State Law (State of New York - Article 24-E, Section 2499w New York State law) that required the state’s Department of Health to publish a booklet that must be received by every woman considering a hysterectomy. It succinctly outlines risks, complications, alternative treatments, and recuperation expectations. Presently, the FDA has a guide on breast implants, but it is not legally mandated that prospective patients receive it. The "FDA Breast Implant Consumer Handbook" was published in 2004. Ciancutti-Leyva told me that the information reads as “a cautionary tale.”
I spoke with Judy Norsigian, Executive Director of Our Bodies Ourselves by telephone, “We see this film as one of the best tools for understanding both the known and unknown consequences of implants for a woman’s health,” she said. The film is an eye opener. In her January 17, 2008 article, “Do My Breast Implants Have a Warranty?” New York Times writer Natasha Singer referenced “Absolutely Safe” as an “anti-implant documentary.” In response to that description, Ciancutti-Leyva said, “Everybody brings their own stuff to the table. I was trying to create a dialogue.”
The two main stories profile a woman and her doctor on the breast augmentation path, contrasted with a woman seeking to have her implants “explanted” by the doctor who supports her decision.
We meet Wendi Myers, a single mother at the time she got silicone implants in the 1990s. Trying to make ends meet by working at an “upscale gentleman’s club” in Houston, her motivation for the procedure was to succeed in her job. In a sardonic definition of the Texas mindset, she explains that in her state the philosophy for everything is “the bigger the better.” Myers, who believed that her implants ruptured in a car accident, started to draw a connection between her symptoms of dizziness, hair loss, and “green and black discharge from her nipples” to the occurrence of the accident. In response to her physical ailments she was told by her original doctor, “It’s all in your head.” It wasn’t until 2006, when Myers met Dr. Edward Melmed, that she found an advocate for her concerns.
Melmed, a plastic surgeon with nearly forty years of practice under his belt, is board certified in the United States, England, Scotland, and South Africa. One of the leading medical voices questioning implant safety, he is on screen with a series of pithy remarks. Early on he offers, “There’s so much smoke, there has to be some fire.” Melmed is not opposed to breast implants, but makes clear, “I don’t believe the implants we’ve got do the trick.” He adds pointedly, “If this was a surgery that was done to men, do you think they would tolerate procedures like this?”
Deneé Dimiceli and her physician, Franklin Rose, are the flip side of the coin. At age twenty-seven, after years of coping with body image insecurity, Dimicelli had breast augmentation surgery. Despite the objections of her husband who says on camera, “It doesn’t make a lot of sense,” she is thrilled that her saline implants (encased by a silicone lining) bring her to a full size C cup. Rose, a board certified plastic surgeon with a national reputation and eighteen-year career in Houston, is adamant about the safety of both silicone and saline implants. He looks to the studies put forth by the Mayo Clinic and Harvard University as his guidelines. When he is introduced to viewers during a pre-op scrub, he mentions that he has performed over 4,000 breast augmentations. He points out that there is “a huge demand for this operation.” While examining Dimiceli he notes, “We are about to take a patient who has very pretty breasts, and make them even prettier.
The remaining voices weigh in like a Greek chorus, commenting on their particular issues and experiences. Audrey Ciancutti and Anne Stansell advocate for breast cancer survivors. Stanselli has repeatedly testified at FDA hearings, to question why implants are represented as part of the mastectomy process.
Dow Corning’s quintessential company man, John Swanson, and his wife Colleen – who had implants – weigh in with John Byrne (Executive Editor of BusinessWeek), who related their story in his book Informed Consent. A classic whistleblower’s tale, Swanson was forced to choose between his corporate affiliation and his relationship to his wife – who believed her lupus and scoloderma symptoms were related to her implants. (Her fears were confirmed when the implants were removed and discovered to be ruptured.) Swanson characterizes the corporate denial as being induced by the profit factor. Byrne posits that the manufacturer never proved the implants were safe, because they didn’t do the due diligence or adequate research in clinical studies to make a conclusion.
Dr. Ernest Lykissa, toxicologist, refers to the implants as “failed devices.” Dr. Michael Harbut, who has treated over 1,000 women with implants and is prominent in the fields of occupational and environmental health, maintains that the platinum and other toxic heavy metals employed in the manufacturing of the silicone gel and silicone shells of breast implants can cause and contribute to serious diseases in the recipients. He has petitioned the FDA, which is self-described on its website as “Protecting and Promoting Your Health,” with the results of his research.
When Dr. Melmed and Dr. Rose represent their specific philosophies, their personalities and demeanor emerge and impact the message. Melmed is matter-of-fact in his delivery, with a touch of ironic wit. He rattles off the three main problems with implants. “They rupture and silicone leaks out. (We don’t know where it goes. We don’t know what it does. We have no idea.) They all get encapsulated. Do they make women ill?” After removing Myers implants, we see that they have ruptured. As he struggles to excise what can best be described as goo, he observes that the implants don’t resemble their original state and offers, “And I’m not sure you want to put this into your 16 year old daughter for graduation…at least I don’t recommend it.”
Dr. Rose, in response to Ciancutti-Leyva, is firm in his opinion that implants are made from “safe bio-material.” He rhetorically asks her, “How many studies do you want to do?” He suggests a reason for the lack of resolution around implant safety. “It keeps coming up because you’ve got all these ultra-liberal feminine groups that keep on beating a drum…and they’re well organized.” In exasperation he tells the filmmaker, “Honey, look. I don’t know how many more times we can keep rehashing the same old thing. I mean they’re safe.”
When women with either silicone or saline implants have mammograms, there is a 30% chance that detection of tumors will be missed. In order to ensure that implants are intact and have not ruptured, women need to have MRIs every two years. If they decide to have them explanted, the cost of the operation for those who had augmentation will not be covered by insurance. (Myers had to borrow $10,000 from her retired parents to fund her procedure.) In considering some of these pragmatic concerns, Ciancutti-Leyva suggests, “I don’t think women are getting all the information.” Norrigan concurs, citing that there have not been sufficient longitudinal studies. It doesn’t help the case for implants to read a list of those “declining to be interviewed” – the Mayo Clinic Study, Allergan Corporation, and Dow Corning Corporation among them – at the close of the film.
Without question, future conversations about breast implants
will have to do more than just scrutinize the medical uncertainties. The need for informed consent was addressed as far back as 2000, in an editorial appearing in the Fall issue of The Journal of the American Medical Women’s Association. Written by Nancy Neveloff Dubler, LLB and Anna Schissel, JD, it was entitled “Women, Breasts, and the Failure of Informed Consent.” The authors examined whether “informed consent for breast augmentation is too fragile a reed to withstand the storm of commerce.” Norrigan sees part of the push for “informed consent” starting with outreach to legislators and policy makers.
A potent brew, comprised of cultural demands in tandem with big advertising dollars spent to promote the desirability of a specific body image, helps to fuel the demand for breast augmentation. In the area of breast reconstruction, options other than implants are not always promoted. In the December 22, 2008 article, “The Choices on Breast Reconstruction Are Not Always Clear,” Natasha Singer delves into why. The two primary reasons are inadequate training for cutting-edge procedures, and profit margin factors for the surgeon.
For any operation, information to reach an educated decision is mandatory. A survey by the American Society of Plastic Surgeons showed that almost 40% of women believed that they should have been more knowledgeable and better advocates for themselves around the choice to receive breast implants.
Clearly, there is something wrong with the picture.
Additional Resources:
“Absolutely Safe” DVD: Alive Mind Media
Breast Implant Information.org: Project of the National Research Center for Women and Families provides the ”most recent research and analysis”
Breast Cancer Action: Articles on Breast Implants
New Attitude: Breast Prosthesis alternatives to Implants
Add a Comment17 Comments
"Absolutely Safe" opened my eyes to the dangers of breasts implants. What really angered me is that a woman with breast cancer is routinely advised by her physician to get implants as though it is all part of her treatment. Thank you Ms. Ciancutti-Leyva for making this informative film. I wish more woman would see it.
June 18, 2009 - 7:20amThis Comment
Absolutely Safe is a very powerful, honest look at the horrfiying concept of breast implants. The director clearly presents different viewpoints and follows one woman who wants implants put in and one who wants them taken out. The juxtaposition of these two journeys is quite powerful. The director bravely confronts a doctor who seems to not have the patient's best interests at heart. All in all a very powerful film that informed me in a much deeper way than most of the research on the subject.
June 17, 2009 - 1:22pmThis Comment
Never will there be TRUE informed consent especially when it comes to breast implants. "Informed Consent BEGINS with INFORMED INDIVIDUALS" - this is our slogan here at Toxic Discovery! You think when you go in for breast implants they tell you everything that is going to happen to your body? As a former surgical nurse I will tell you that is NOT the case. Breast implants are a foreign device - in another 20 years society will view this procedure as barbaric! Something that was done to women as a human experiment. Women are spoon fed from the cradle to the grave what they should look like - isn't it time we understand 'YOU CAN'T FOOL MOTHER NATURE"?
Missouri is the 2nd State in the Nation to have an Informed Consent Law concerning breast implants which was passed into law in the year 2000. We continue to be the SHOW ME STATE when it comes to protection laws against women and children.
World Literature can just be JUNK SCIENCE if not researched and studied correctly - Over 2 million women live the lie's of of so called research - Want the TRUTH? The MDL and SF-DCT hold the medical records of thousands of women who are "suffering in silence" daily and who have proven medical records that document what the Manufacturers and Plastic Surgeons really don't want you to know. That breast implants rupture and breast implants can and do make you ill.
Want more information - Call Toxic Discovery - www.toxicdiscovery.com
Kathy L. Keithley-Johnston, R.N.
June 17, 2009 - 3:37pmExecutive Director/Founder/Injured Consumer
This Comment
You are absolutely 100% right. Thank you. A piece of my story is 5 below you.
Thanks, Cheryl
June 19, 2009 - 8:03pmThis Comment
One has to only take a closer look at "international consensus" to realize who has funded many of these studies (ex. companies who supply implants and their big dollars) and the studies themselves like the Mayo Clinic (which refuses to be interviewed) to see how questionable these studies are. People pop these implants in like they were gum drops without any knowledge at all of the risks involved.
June 17, 2009 - 11:11amThe least that needs to be done is having informed consent along with the "FDA Breast Implant Consumer Handbook" where a patient can read about the risks involved.
What is a farce is the way our society is duped by large corporations and their profits they engender into thinking these operations are "absolutely safe"!
This Comment
The movie absolutely safe was so reassuring for me that my explantation was necessary. Today I feel much better and thanks to the movie know my symptoms were very real. -Mary Agramonte
June 17, 2009 - 10:11amThis Comment
"Absolutely Safe" is an absolute farce as a documentary. It's a strong POV film which ignores and dismisses international consensus about the risks associated with breast implants. There have been close to 2 dozen comprehensive reviews of the world literature on this subject performed by health ministries around the world which have all been consistant in their conclusions.
While I think there are certainly improvements that can be made in informed consent, this has to do more with reoperations rather then health issues.
June 17, 2009 - 9:55amThis Comment